Details of the study
The study – the largest 2ndgeneration TAVI FIM study ever conducted – was conducted at 5 sites in Germany: Leipzig Herzzentrum, Kerckhoff-Klinik Bad Nauheim, Freiburg Universitäts Spital, Westdeutsches Herzzentrum Essen and Universitäres Herzzentrum Hamburg. Forty (40) patients with severe aortic stenosis were recruited and treated with ACURATE TA™. The average age of treated patients was 83 years with a mean Logistic EuroScore of 21.5% and STS Score of 9.0%.

Results
Successful valve implantation with the ACURATE TA™ occurred in 38 patients (95.0%). One patient received a valve-in-valve using a commercially available transapical valve and one patient was converted to sAVR. Only one patient required a new pacemaker post-implant.30-day mortality was 12.5% including 3 deaths from non-valve-related respiratory complications. Comprehensive 30-day results will be presented at the Dallas / Leipzig International Valve conference in December 2010.

Dr. Joërg Kempfert of Leipzig Herzzentrum commented: “The ACURATE TA™ is truly intuitive, easy to use, reliable and covers the full spectrum of severe aortic stenosis. We look forward to the Pilot study to confirm the excellent results obtained in this comprehensive FIM study”

Laura Brenton, VP Clinical / Regulatory Affairs, added: “The ease of use of the ACURATETA™ was acknowledged by all physicians participating in the study. Additionally, the learning curve was significantly shorter than that of competitive systems. Furthermore, the robust size of the FIM allows for comparison of its initial data to published statistics from competitors suggesting comparable or improved initial outcomes.”

Jacques R. Essinger, CEO of Symetis, added: “ACURATE™ TA is the second generation TAVI system with the largest clinical experience to date. We are building on this competitive advantage by soon beginning a pilot clinical study, a major step toward achieving European compliance and the CE mark.”